APPLICATION
ANDA073484
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-29
LATEST ACTION
2026-04-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
VALPROIC ACIDPrescription
VALPROIC ACID 250MG · CAPSULE · ORAL
Approval history
2026-04-08Labeling · Supplement 51 · standardAP
2022-01-14Labeling · Supplement 42 · standardAP
2022-01-14Labeling · Supplement 39 · standardAP
2019-12-09Labeling · Supplement 38 · standardAP
2019-12-09Labeling · Supplement 34 · standardAP
2019-12-09Labeling · Supplement 32 · standardAP
2019-12-09Labeling · Supplement 37 · standardAP
2019-12-09Labeling · Supplement 31 · standardAP
2015-11-30Labeling · Supplement 28 · standardAP
2015-11-30Labeling · Supplement 26 · standardAP
2015-11-30Labeling · Supplement 30 · standardAP
2015-11-30Labeling · Supplement 27 · standardAP
2014-12-10Labeling · Supplement 24 · standardAP
2014-12-10Labeling · Supplement 22 · standardAP
2014-12-10Labeling · Supplement 25 · standardAP
2014-12-10Labeling · Supplement 23 · standardAP
2011-01-25Labeling · Supplement 20AP
2010-01-12Labeling · Supplement 18AP
2008-04-01Labeling · Supplement 17AP
2007-09-23Labeling · Supplement 14AP
2006-12-17Labeling · Supplement 13AP
1997-10-08Manufacturing (CMC) · Supplement 6AP
1996-01-30Manufacturing (CMC) · Supplement 1AP
1994-08-02Manufacturing (CMC) · Supplement 4AP
1994-08-02Manufacturing (CMC) · Supplement 2AP
1994-08-02Manufacturing (CMC) · Supplement 3AP
1993-06-29OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.